Apparatus for enhanced delivery of treatment device to the intervertebral disc annulus

ABSTRACT

The present invention provides methods and devices for enhancing the delivery of treatment devices for treating the annulus of an intervertebral disc. The methods and devices may employ delivery support elements to delivery tools used to deliver expandable treatment devices to the intervertebral disc. Fixation devices and methods are also disclosed, which may help to secure the treatment device in place.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/235,764 filed Sep. 26, 2005, which is a continuation-in-part of U.S.patent application Ser. No. 11/120,750 filed May 3, 2005, now U.S. Pat.No. 7,615,076, which is a continuation-in-part of U.S. patentapplication Ser. No. 10/352,981 filed Jan. 29, 2003 and acontinuation-in-part of U.S. patent application Ser. No. 10/327,106filed Dec. 24, 2002, now U.S. Pat. No. 7,004,970, each of which arecontinuations-in-part of U.S. patent application Ser. No. 10/133,339filed Apr. 29, 2002, now U.S. Pat. No. 7,052,516, which is acontinuation-in-part of U.S. patent application Ser. No. 09/947,078,filed Sep. 5, 2001, now U.S. Pat. No. 6,592,625, issued Jul. 15, 2003,which is a continuation of U.S. patent application Ser. No. 09/484,706,filed Jan. 18, 2000, which claims the benefit of U.S. ProvisionalApplication No. 60/160,710, filed Oct. 20, 1999. This application alsoclaims, through U.S. patent application Ser. No. 10/133,339, the benefitof U.S. Provisional Application No. 60/309,105, filed Jul. 31, 2001.This application is also related to, and claims the benefit of, U.S.patent application Ser. No. 10/075,615, filed on Feb. 15, 2002. All areincorporated herein by reference in their entirety.

TECHNICAL FIELD

The invention generally relates to methods and devices for the closure,sealing, repair, augmentation, reconstruction or otherwise treatment ofan intervertebral disc annulus, and accompanying delivery devices andtools, and their methods of use. The repair can be of an aperture in thedisc wall, or a weakened or thin portion. The term “aperture” refers toa hole in the annulus that is a result of a surgical incision ordissection into the intervertebral disc annulus, or the consequence of anaturally occurring tear (rent). The invention generally relates tosurgical devices and methods for the treatment of intervertebral discwall repair or reconstruction. The invention further relates to anannular repair device, or stent, for annular disc repair. These implantscan be of natural or synthetic materials. The effects of saidreconstruction is restoration of disc wall integrity, which may reducethe failure rate (3-21%) of a common surgical procedure (disc fragmentremoval or discectomy), or advantageously provide a barrier tointradiscal material migration. In particular, the invention furtherrelates to an enhanced delivery method and device for the delivery of apatch, mesh, barrier, scaffold, or other implant to treat anintervertebral disc.

BACKGROUND

The spinal column is formed from a number of bony vertebrae, which intheir normal state are separated from each other by intervertebraldiscs. These discs are comprised of the annulus fibrosus, and thenucleus pulposus, both of which are soft tissue. The intervertebral discacts in the spine as a crucial stabilizer, and as a mechanism for forcedistribution between adjacent vertebral bodies. Without a competentdisc, collapse of the intervertebral disc may occur, contributing toabnormal joint mechanics and premature development of degenerativeand/or arthritic changes.

The normal intervertebral disc has an outer ligamentous ring called theannulus surrounding the nucleus pulposus. The annulus binds the adjacentvertebrae together and is constituted of collagen fibers that areattached to the vertebrae and cross each other so that half of theindividual fibers will tighten as the vertebrae are rotated in eitherdirection, thus resisting twisting or torsional motion. The nucleuspulposus is constituted of soft tissue, having about 85% water content,which moves about during bending from front to back and from side toside.

The aging process contributes to gradual changes in the intervertebraldiscs. The annulus loses much of its flexibility and resilience,becoming more dense and solid in composition. The aging annulus may alsobe marked by the appearance or propagation of cracks or fissures in theannular wall. Similarly, the nucleus desiccates, increasing viscosityand thus losing its fluidity. In combination, these features of the agedintervertebral discs result in less dynamic stress distribution becauseof the more viscous nucleus pulposus, and less ability to withstandlocalized stresses by the annulus fibrosus due to its desiccation, lossof flexibility and the presence of fissures. Fissures can also occur dueto disease or other pathological conditions. Occasionally fissures mayform rents through the annular wall. In these instances, the nucleuspulposus is urged outwardly from the subannular space through a rent,often into the spinal column. Extruded nucleus pulposus can, and oftendoes, mechanically press on the spinal cord or spinal nerve rootlet.This painful condition is clinically referred to as a ruptured orherniated disc.

In the event of annulus rupture, the subannular nucleus pulposusmigrates along the path of least resistance forcing the fissure to openfurther, allowing migration of the nucleus pulposus through the wall ofthe disc, with resultant nerve compression and leakage of chemicals ofinflammation into the space around the adjacent nerve roots supplyingthe extremities, bladder, bowel and genitalia. The usual effect of nervecompression and inflammation is intolerable back or neck pain, radiatinginto the extremities, with accompanying numbness, weakness, and in latestages, paralysis and muscle atrophy, and/or bladder and bowelincontinence. Additionally, injury, disease or other degenerativedisorders may cause one or more of the intervertebral discs to shrink,collapse, deteriorate or become displaced, herniated, or otherwisedamaged and compromised.

Surgical repairs or replacements of displaced or herniated discs areattempted approximately 390,000 times in the USA each year.Historically, there has been no known way to repair or reconstruct theannulus. Instead, surgical procedures to date are designed to relievesymptoms by removing unwanted disc fragments and relieving nervecompression. While results are currently acceptable, they are notoptimal. Various authors report 3.1-21% recurrent disc herniation,representing a failure of the primary procedure and requiringre-operation for the same condition. An estimated 10% recurrence rateresults in 39,000 re-operations in the United States each year.

Some have also suggested that the repair of a damaged intervertebraldisc might include the augmentation of the nucleus pulposus, and variousefforts at nucleus pulposus replacement have been reported. The presentinvention is directed at the repair of the annulus, whether or not anuclear augmentation is also warranted.

SUMMARY

The present inventions provide methods and devices related to enhancingthe delivery of devices for reconstruction of the disc wall in cases ofdisplaced, herniated, thinned, ruptured, or otherwise damaged orinfirmed intervertebral discs. In accordance with the invention, anenhanced device and method is disclosed for the delivery of devices totreat an intervertebral disc having an aperture, weakened or thinportion in the wall of the annulus fibrosis of the intervertebral disc.Repair, reconstruction, sealing, occluding an aperture, weakened or thinportion in the wall of the annulus may prevent or avoid migration ofintradiscal material from the disc space. The method and device of thepresent invention allows controlled delivery of an expandable device asdescribed in, for example, pending U.S. patent application Ser. No.11/120,750, filed May 3, 2005. Reference is made to pending applicationsas listed above for further details about the various treatment devices,their construction and other attributes of their deliveries. Thisapplication is to further describe an invention that may be utilized toenhance the delivery of these various implants. While multipleembodiments are disclosed, still other embodiments of the presentinvention will become apparent to those skilled in the art from thefollowing detailed description, which shows and describes illustrativeembodiments of the invention. Accordingly, the drawings and detaileddescription are to be regarded as illustrative in nature and notrestrictive.

The method and device of the invention includes, in one embodiment, thesteps of providing a first delivery tool having a proximal end and adistal end, the distal end carrying a treatment device; introducing thedistal end of the first delivery tool at least partially into theintervertebral disc space; and deploying said treatment device saidtreatment delivery tool also comprising means to enhance the controlledopening of the treatment device.

It is also anticipated that the treatment devices and their deliverytools may be used in combination with fixation devices as described inprevious pending applications identified above.

The objects and various advantages of the invention will be apparentfrom the description which follows. In general, the implantable medicaltreatment devices are placed, positioned, and subsequently affixed inthe annulus to reduce re-extrusion of the nucleus or other intradiscalmaterial through an aperture by: establishing a barrier or otherwiseclosing or partially closing an aperture; and/or helping to restore thenatural integrity of the wall of the annulus; and/or promoting healingof the annulus. Increased integrity and faster and/or more thoroughhealing of the aperture may reduce future recurrence of herniation ofthe disc nucleus, or intradiscal material, from the intervertebral disc,and the recurrence of resulting radicular or back pain. In addition, itis believed that the repair of the annular tissue could promote enhancedbiomechanics and reduce the possibility of intervertebral disc heightcollapse and segmental instability, thus possibly avoiding recurrentradicular or back pain after a surgical procedure.

Moreover, the repair of an annular aperture (after for example, adiscectomy procedure) with the reduction of the re-extrusion of thenucleus may also advantageously reduce adhesion formation surroundingthe nerve roots. The nuclear material of the disc is toxic to the nervesand is believed to cause increased inflammation surrounding the nerves,which in turn can cause increased scar formation (adhesions or epiduralfibrosis) upon healing. Adhesions created around the nerve roots cancause continued back pain. Any reduction in adhesion formation isbelieved to reduce future recurrence of pain.

Annular repair devices and methods may create a mechanical barrier tothe extrusion of intradiscal material (i.e., nucleus pulposus, ornuclear augmentation materials) from the disc space, add mechanicalintegrity to the annulus and the tissue surrounding an aperture,weakened, or thin portion of the wall of the annulus, and promote fasterand more complete healing of the aperture, weakened or thin portion.

Although much of the discussion is directed toward the repair of theintervertebral disc after a surgical procedure, such as discectomy (asurgical procedure performed to remove herniated fragments of the discnucleus), it is contemplated that the devices of the present inventionmay be used in other procedures that involve access (whether induced ornaturally occurring) through the annulus of the intervertebral disc, orprophylactic application to the annulus. An example of another procedurethat could require a repair technique involves the replacement of thenucleus (nucleus replacement) with an implantable nucleus material toreplace the functioning of the natural nucleus when it is degenerated.The object of the invention in this case would be similar in that therepair would maintain the replacement nucleus within the disc space.

According to one embodiment of the present invention, treatment deliverydevices such as the delivery devices described in FIGS. 43 to 46 andFIGS. 57 to 64 may be used to place annular treatment devices which areemployed to repair an aperture, degenerated, weakened, or thin portionin an intervertebral disc annulus. Placement of a treatment device asdepicted, for example, in FIGS. 43 to 46 into disc tissue below thesurface of an annular aperture and deploying the device to reach anoptimal configuration to occlude, close, repair, augment, or otherwisetreat an aperture, weakened or thin portion of the annulus fibrosus maybe challenging since the device is placed with little directvisualization. A treatment device placed below the surface of theannulus is preferably inserted into the disc with a diminished dimensionto allow the device to be placed through and below the aperture surface,while preferably obtaining a delivery and deployed state that is larger,acting to bridge the aperture below the outer annular surface. Since asurgeon is unable to visualize the delivery of the implant into an“open” deployed configuration, the ability to assure that the devicereliability obtains the desired, open configuration is important.Complicating the delivery is the need for the treatment device to beable to move or push softer tissue aside (i.e., nucleus pulposus andinner layers of annulus fibrosus) during delivery to appropriatelysituate itself in a bridging relationship over the aperture, weakened,or thin portion of the annulus needing repair. Moreover, the deliverydevice of the present invention also allows for the surgeon to be ableto deploy the device in the subannular space and “seat” (e.g., pullingthe delivery device in a proximal direction) the implant device againstinner layers of the annulus without deforming the device in a mannerthat may compromise the implant's ability to reach a maximal deployment.The following description is exemplary of an enhanced delivery devicethat provides for increased “leverage” in the delivery and thedeployment of a patch that is delivered to the intervertebral discrequiring repair, whether or not there may be additional elements of thedevice to further acutely secure the device to disc tissue, such assutures, staples, anchor bands, barbs, tension bands, adhesives, orother acute fixation elements known to those skilled in the art.

The inventive treatment delivery device can be used with a variety ofrepair devices to seal, reconstruct and/or repair the intervertebraldisc, as described in other pending applications, for example, implantdevices found in FIGS. 2-4, 9, 10, 12-20, and 27-32. This list is notintended to be exclusionary but rather exemplary. In some of the devicesdescribed therein, there is: a reconfigurable device (note: patch,stent, implant, device, mesh, barrier, scaffold and treatment device arehere used interchangeably) that has, in use, at least a portion of thedevice in the sub-annular space of the intervertebral disc annulus. Inparticular, the enhanced delivery device of the present invention willbe described in further detail with respect to one of the embodiments ofan annular patch delivery, as seen in FIGS. 33 to 64. The description isnot intended to be exclusive to the delivery of the braided treatmentdevice, but it is intended to exemplify the use of an enhanced deliverytool and one skilled in the art could readily apply the invention in avariety of delivery devices and repair implants

Some of the concepts disclosed hereinbelow may advantageouslyadditionally incorporate design elements to reduce the number of steps(and time), and/or simplify the surgical technique, and/or reduce therisk of causing complications during the repair of the intervertebraldisc annulus. In addition, the following treatment devices may becomeincorporated by the surrounding tissues, or to act as a scaffold in theshort-term (3-6 months) for tissue incorporation, creating a subannularbarrier in and across the aperture by placement of a patch ofbiocompatible material acting as a bridge or a scaffold, providing aplatform for traverse of fibroblasts or other normal cells of repairexisting in and around the various layers of the disc annulus.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate illustrative embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention. While the invention is amenable to variousmodifications and alternative forms, specific embodiments have beenshown by way of example in the drawings and are described in detailbelow. The intention, however, is not to limit the invention to theparticular embodiments described. On the contrary, the invention isintended to cover all modifications, equivalents, and alternativesfalling within the scope of the invention as defined by the appendedclaims.

FIG. 1 shows a primary closure of an opening in the disc annulus.

FIGS. 2-2A show a primary closure with a stent.

FIGS. 3A-3D show an annulus stent being inserted into and expandedwithin the disc annulus.

FIGS. 4A-4C shows a perspective view of a further illustrativeembodiment of an annulus stent, and collapsed views thereof.

FIGS. 5A-5C show the annulus stent of FIG. 4A being inserted into thedisc annulus.

FIGS. 6A-6C show a method of inserting the annulus stent of FIG. 4A intothe disc annulus.

FIG. 7 shows an illustrative embodiment of an introduction device for anannulus stent.

FIG. 8 shows a variation of the device depicted in FIG. 7.

FIGS. 9A-9C show an exemplary introduction tool for use with the devicesof FIGS. 7 and 8 with a stent deflected.

FIGS. 10A-10B show a still further illustrative embodiment of an annulusstent employing secondary barbed fixation devices.

FIG. 11A shows a herniated disc in perspective view, and FIG. 11B showsthe same disc after discectomy.

FIGS. 12A-12G show a still further illustrative embodiment of anintroduced and expanded annulus stent/patch being fixated and theaperture reapproximated.

FIGS. 13A-13C schematically depict a still further embodiment of theinvention where an expandable stent/patch is tethered in situ using acinch line.

FIGS. 14A-14C schematically depict the patch of FIG. 13 being fixatedthrough use of a barbed surgical staple device and a cinch line.

FIGS. 15A-15C schematically depict a still further embodiment of theinvention where an expandable stent/patch is tethered in situ using acinch line.

FIGS. 16A-16C schematically depict the stent/patch of FIG. 15 beingfixated through use of a barbed surgical staple device that penetratesthe patch/stent and a cinch line.

FIG. 17 depicts an exemplary use of filler material within the apertureduring placement of a patch/stent tethered by a cinch line.

FIGS. 18A-18E show exemplary embodiments of various additionalpatch/stent fixation techniques.

FIG. 19 shows a still further illustrative embodiment of a stent/patchhaving a frame.

FIGS. 20A-20C show a still further exemplary embodiment of the inventionhaving external fixation anchors.

FIGS. 21A-21C show still further embodiments of the invention havingexternal fixation anchors.

FIGS. 22A-22C show still further embodiments of the invention havingexternal fixation anchors.

FIG. 23 shows a delivered configuration of fixation means that mayresult from the use of a single, or multiple, devices to delivermultiple barbs, anchor, or T-anchors sequentially or simultaneously.

FIGS. 24A-24B show an illustrative configuration of an anchor banddelivery device.

FIGS. 25A-25D show an anchor band delivery device comprising twodevices, each with at least one T-anchor (barbs) and band with pre-tiedknot and optional knot pusher according to illustrative embodiments ofthe invention.

FIG. 26 shows an anchor and band delivery device according to oneembodiment of the invention.

FIGS. 27A-27B show, respectively, a lateral view of a still furtherexemplary embodiment of the present invention having a braidedarrangement in a collapsed configuration and an axial view of theexemplary embodiment in an expanded configuration.

FIG. 28 shows a lateral view of the exemplary embodiment of FIG. 27A ina collapsed configuration mounted on an illustrative delivery device.

FIG. 29 shows a lateral cutaway view of the exemplary embodiment of FIG.27A in a collapsed configuration.

FIG. 30 shows a lateral cutaway view of the exemplary embodiment of FIG.27B in an expanded configuration.

FIG. 31 shows a lateral view of an illustrative delivery member as shownin the exemplary embodiment of FIGS. 29 and 30.

FIG. 32 shows a lateral view of an exemplary embodiment of the inventionin an expanded configuration subannularly.

FIG. 33 shows a transverse view of a treatment device mounted on adelivery tool in an unexpanded configuration in the subannular cavity.

FIG. 34 shows a transverse view of the treatment device being deployedinto an expanded configuration in the subannular cavity.

FIG. 35 shows a transverse view of the treatment device fully deployedand adjacent the annular wall.

FIG. 36 shows a transverse view of the placement of a fixation elementdelivery device into the deployed treatment device.

FIG. 37 shows a transverse view of the placement of a fixation elementthrough the treatment device and the annular wall.

FIG. 38 shows a transverse view of after affixing a fixation elementdelivered in FIG. 37 and partial removal of the fixation elementdelivery device.

FIG. 39 shows a transverse view of the fixation element after removal ofthe fixation element delivery tool.

FIG. 40 shows a transverse view of an additional fixation element lockedin place on the opposite side of the treatment device.

FIG. 41 shows a transverse view of the removal of the treatment devicedelivery tool.

FIG. 42 shows a sagittal view of an illustrative embodiment of atreatment device mounted on a delivery tool in an unexpandedconfiguration in the subannular cavity.

FIG. 43 shows a sagittal view of after affixing a fixation element tothe treatment device of FIG. 42.

FIG. 44 shows a sagittal view of the placement of a fixation elementdelivery tool through the treatment device and the annular wall.

FIG. 45 shows a sagittal view of the placement of an additional fixationelement through the treatment device and the annular wall.

FIG. 46 shows a sagittal view after the removal of the fixation elementdelivery tool.

FIG. 47 is a view of the anchor band delivery tool pre-deployment incross section.

FIG. 48 shows a detail of the distal end of the anchor band (fixationelement) delivery tool in cross section.

FIG. 49 shows a detail of the slide body and cannula anchor of anexemplary fixation element delivery tool in cross section.

FIG. 50 is a view of the anchor band delivery tool in cross sectionduring a deployment cycle.

FIG. 51 is a detail of the distal end of the anchor band delivery tooldepicted in FIG. 50.

FIG. 52 shows a detail of the slide body and cannula anchor of anexemplary fixation element delivery tool in cross section during adeployment cycle.

FIG. 53 shows a detail of the suture retention block and blade assemblyof the anchor band delivery tool.

FIG. 54 is a view of the anchor band delivery tool in cross sectionduring the cutting of the suture tether and release of the anchor band.

FIG. 55 shows a detail of the distal end of the anchor band deliverytool during release of the anchor band.

FIG. 56 shows a detail of the shows a detail of the suture retentionblock and blade assembly of the anchor band delivery tool during thecutting of the tether.

FIG. 57 depicts an illustrative embodiments of a therapeutic devicedelivery tool (TDDT).

FIG. 58 shows a detail of the distal end of the therapeutic devicedelivery tool with a therapeutic device mounted thereon.

FIG. 59 depicts the deployment of a therapeutic device using the TDDT.

FIG. 60 depicts a detail of the distal end of the TDDT during deploymentof a therapeutic device.

FIG. 61 depicts the TDDT during release of the therapeutic device.

FIG. 62 is a detail view of the distal end of the TDDT during release ofthe therapeutic device.

FIG. 63 is a plan view along the axis of an expanded exemplarytherapeutic device, showing the engagement of the TDDT latch.

FIG. 64 is a plan view along the axis of an expanded exemplarytherapeutic device, showing the disengagement of the TDDT latch.

FIG. 65 shows a sagittal view of an illustrative embodiment of atreatment device mounted on a delivery tool in an unexpandedconfiguration in the subannular cavity, with enhanced delivery supportelement 540.

FIG. 66 shows a sagittal view of FIG. 65 after deployment and seating ofthe treatment device.

FIG. 67 depicts illustrative embodiments of the proximal end of atherapeutic device delivery tool (TDDT) with enhanced delivery supportelements 540 prior to treatment device deployment.

FIG. 68 depicts illustrative embodiments of the proximal end of atherapeutic device delivery tool (TDDT) with enhanced delivery supportelements 540 during treatment device deployment.

FIG. 69 depicts detail illustrative embodiments of the distal end of theTDDT with an enhanced delivery support elements 540 during deployment ofa therapeutic device.

FIG. 70 depicts illustrative embodiments of the proximal end of atherapeutic device delivery tool (TDDT) with enhanced delivery supportelements 540 after deployment of a treatment device.

FIG. 71 depicts detail illustrative embodiments of the distal end of theTDDT with an enhanced delivery support elements 540 after deployment ofa therapeutic device.

FIG. 72 illustrates an alternative embodiment of the distal portion ofthe TDDT during the deployment of a therapeutic device with deliverysupport elements 540 and a element collar 544.

FIG. 73 illustrates an alternative embodiment of the distal portion ofthe TDDT during the deployment of a therapeutic device with deliverysupport element 540.

FIG. 74 illustrates an alternative embodiment of the distal portion ofthe TDDT and treatment device during the deployment of a therapeuticdevice and with delivery support element 540 that may be integral withthe treatment device.

FIG. 75 illustrates an alternative embodiment of the distal portion ofthe TDDT and treatment device during the deployment of a therapeuticdevice and with delivery support element 540 that may be integral withthe treatment device.

DETAILED DESCRIPTION

Reference will now be made in detail to selected illustrativeembodiments of the invention, with occasional reference to theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

As discussed in previous pending applications, it is understood thatthere can be a variety of device designs ofpatches/stents/implants/meshes/devices/treatment devices to repairdamaged annular tissue and/or otherwise facilitate maintaining otherintradiscal materials within the disc space. These devices can beconstructed of single components or multiple components, with a varietyof different materials, whether synthetic, naturally occurring,recombinated (genetically engineered) to achieve various objectives inthe delivery, deployment and fixation of a device to repair orreconstruct the annulus. The following device concepts are furtherdiscussed for additional embodiments of a device and/or system for therepair of an intervertebral disc annulus. The following descriptionswill illustratively depict and describe methods, devices, and tools todeliver a treatment to an intervertebral disc after a, lumbar discectomyprocedure; although, it is anticipated that these methods, devices, andtools may be similarly used in a variety of applications. As an example,the embodiments described herein may also advantageously maintainmaterials within the disc space other than natural disc tissue (nucleus,annulus, cartilage, etc.), such as implants and materials that may beused to replace and/or augment the nucleus pulposus or other parts ofdisc's tissues. These procedures may be performed to treat, for example,degenerative disc disease. Whether these materials are intended toreplace the natural functioning of the nucleus pulposus (i.e.,implantable prosthetics or injectable, in-situ curable polymer protein,or the like) or provide a fusion between vertebral bodies (i.e.,implantable bony or synthetic prosthetics with materials to facilitatefusion, such as growth factors like bone morphogenic proteins) oneskilled in the art would realize that variations to the embodimentsdescribed herein may be employed to better address characteristicdifferences in the various materials and/or implants that could beplaced within the intervertebral disc space, and that these variationswould be within the scope of the invention.

Furthermore, it should be noted that surgeons differ in their techniquesand methods in performing an intervention on a spinal disc, and theinventive descriptions and depictions of methods, devices and deliverytools to repair annular tissue could be employed with a variety ofsurgical techniques; such as, but not limited to: open surgical,microsurgical discectomy (using a magnifying scope or loupes), minimallyinvasive surgical (through, for example, a METRx™ system available fromMedtronic, Inc.), and percutaneous access. Surgeons may also employ avariety of techniques for intra-operative assessment and/orvisualization of the procedure, which may include: intraoperativeprobing, radiography (e.g., C-arm, flat plate), and endoscopy. It iscontemplated that the inventive embodiments described are not limited bythe various techniques that may be employed by the surgeon.

In addition, the surgical approach to the intervertebral disc throughoutthe figures and descriptions depict a common approach, with relatedstructures, to a lumbar discectomy; although, it is possible thatsurgeons may prefer alternative approaches to the intervertebral discfor various applications (for example, different intervertebral disclevels such as the cervical or thoracic region, or for nucleusaugmentation), which may include, but is not limited to:posterior-lateral, anterior, anterior-lateral, transforaminal,extra-foraminal, extrapedicular, axial (i.e., through the vertebralbodies), retroperitoneal, trans psoas (through the Psoas muscle),contralateral, and along the spinal foramen. The approach to theintervertebral disc space should not be interpreted to limit the use ofthe invention for the repair or reconstruction of the an aperture,weakened or thin portion of the annulus, as described herein.

It is also important to note that the boundary in the intervertebraldisc space between the annulus fibrosus and the nucleus pulposus asdepicted herein may be demarked or otherwise highlighted; however, it isimportant to recognize that these tissues are not as precisely demarkedin human tissues, and may be even less so as the patient ages or evincesdegeneration of the intervertebral disc. This demarcation may beespecially difficult to discern during an operative procedure, using forexample; available surgical tools (i.e., probes), fluoroscopic guidance(x-ray), or visual (endoscope) guidance. However, in general, the layersof the annulus have more structural integrity (and strength) than thenucleus, and this integrity varies from the outer most layers of theannulus being of higher structural integrity than the inner most layersof the annulus.

Moreover, the drawings and descriptions herein are necessarilysimplified to depict the operation of the devices and illustrate varioussteps in the method. In use, the tissues may be manipulated by, and arefrequently in contact with, the various tools and devices; however, forclarity of construction and operation, the figures may not show intimatecontact between the tissues the tools and the devices.

As depicted in FIG. 11A, a herniated disc occurs when disc nucleusmaterial emerges from the subannular region and outside of the disc.Herniated disc nucleus material then impinges on nerve tissue, causingpain. A discectomy attempts to relieve pressure on the nerve tissuethrough surgical removal of disc material, the result usually being anaperture in the disc annulus wall, and usually a void in the subannularspace where disc nucleus was removed, as shown in FIG. 11B. FIG. 11Btypifies a disc after the discectomy procedure has been performed, as domost of the drawings and descriptions contained herein. However, itshould be understood that in order to perform a discectomy procedure,there are a variety of instruments and tools readily available to thesurgeon during spine surgery, or other surgical procedures, to obtainthe outcome as shown in FIG. 11, or other outcomes intended by thesurgeon and the surgical procedure. These tools and instruments may beused to: incise, resect, dissect, remove, manipulate, elevate, retract,probe, cut, curette, measure or otherwise effect a surgical outcome.Tools and instruments that may be used to perform these functions mayinclude: scalpels, Cobb elevators, Kerrison punch, various elevators(straight, angled, for example a Penfield), nerve probe hook, nerveretractor, curettes (angled, straight, ringed), rongeurs (straight orangulated, for example a Peapod), forceps, needle holders, nerve rootretractors, scissors. This list is illustrative, but is not intended tobe exhaustive or interpreted as limiting. It is anticipated that some ofthese tools and/or instruments could be used before, during, or afterthe use of the inventive methods, devices and tools described herein inorder to access, probe (e.g., Penfield elevator), prepare (e.g., angledor ringed curette, rongeur, forceps), and/or generally assess (e.g.,angled probe) treatment site or facilitate the manipulation (e.g.,forceps, needle holder), introduction (e.g., forceps, needle holder,angled probe), or deployment (e.g., forceps, needle holder, angledprobe) of the treatment device and/or its components.

The are a variety of ways to affix a device to the wall of the annulusin addition to those discussed hereinabove. The following exemplaryembodiments are introduced here to provide inventive illustrations ofthe types of techniques that can be employed to reduce the time andskill required to affix the patch to the annulus, versus suturing andtying a knot.

An exemplary embodiment of the enhanced method and device of a treatmentdelivery tool is the description of an enhanced delivery of the braideddevice as depicted in FIGS. 24 to 32, FIGS. 33 to 46, and FIGS. 57 to64. As described previously in pending U.S. patent application Ser. No.11/120,750, FIGS. 33-46 depict an illustrative method for the deploymentof a treatment device into the intervertebral disc 200. As describedpreviously, there are a variety of applications, approaches, techniques,tools, and methods for accessing and performing spinal disc surgerywhich may be dependent on physician preferences and could be arbitrary.Therefore, the following description and depiction of the method shouldbe considered illustrative and not limiting. In the illustrativescenario which is used in the following descriptions, and with referenceto FIG. 33, the disc 200, which is comprised of the annulus fibrosus 202and the nucleus pulposus 204, is shown in a transverse cross section.The disc 200, as described above, is disposed anatomically betweencaudal and cephalad vertebral bodies, which a portion of a vertebralbody (spinous process 206) is seen in FIG. 30. The disc 200 may beaccessed for treatment via a surgical incision 208 made in theparamedian region lateral of the spinal canal 210. A microdiscectomyprocedure may precede the placement of a treatment device in order toremove disc fragments and to provide a subannular cavity 212. Thesubannular cavity 212, however, may be preexisting or may be created forthe purpose of performing a nuclear augmentation. An aperture 214 in theannulus provides a path for the mesh or treatment device delivery tool500 to place treatment device 600. The treatment device 600 can take theform as described in the embodiments above, or as additionally describedbelow with reference to FIGS. 63-64, as described in commonly-assignedcopending U.S. patent application Ser. No. 10/352,981, filed on Jan. 29,2003 and incorporated herein by reference, or any other appropriateform. Likewise, the anchor band delivery device 400 can take the form asdescribed in the embodiments above, or as additionally described belowwith reference to FIGS. 47-52, as described in commonly-assignedcopending U.S. patent application Ser. No. 10/327,106, filed on Dec. 24,2002 and incorporated herein by reference or any other appropriate form.

As shown in FIG. 33, a delivery device 500 is introduced throughsurgical incision 208 to traverse aperture 214 and position treatmentdevice 600 in subannular cavity 212. As depicted, treatment device 600is in a first configuration sized to permit its passage to thesubannular cavity 212. FIG. 42 shows a detail, sagittal view of meshdevice 600 mounted on the distal portion 602 of delivery tool 500,introduced to the cavity. Also shown are sections of intervertebral disctissues. As illustrated, treatment device 600 may have element 608 tolatch the mesh device once deployed into its final deployedconfiguration. If required, there may be a variety of ways to latch,lock or otherwise secure the device in its final configuration, asdescribed previously, or additionally depicted and described below inFIGS. 71A-E.

As depicted in FIG. 34, the treatment device delivery tool 500 can bemanipulated by, for example, pulling a finger grip 502 in the directionof arrow 300 to deploy treatment device 600 in the subannular cavity212. As illustrated here, this deployment involves a longitudinalshortening of the treatment device, drawing end 606 toward end 604,resulting in a lateral expansion of the treatment device 600. Thepulling of the finger grip 502 may be preceded by the release of asafety lock 504 preventing deployment of the treatment device untilintended by the surgeon. As illustrated here, the lock is releasedthrough rotation of handle member 504 in the direction of arrow 302.Also shown is a marking 538 on the delivery tool 500 that may visuallyassist the surgeon in assessing the degree to which the device has beenplaced in subannular space.

FIG. 35 shows the finger grip 502 reaching its intended limit, and theconcomitant full intended deployment of treatment device 600, where end606 reaches its intended design position for the deployed configurationof the device 600. In this illustrative depiction, end 606 is pulledadjacent to end 604, and device 600 has reached its maximum intendedlateral expansion. As shown, the deployed device 600 may be pulled tointernally engage and at least partially conform to the cavity 212.Naturally, the full travel of the finger grip 502 can be determined bythe design of the delivery device, or informed by the judgment of thesurgeon through visualization, tactile realization, or the like. Oncethe intended limit has been achieved and the device fully deployed, thedelivery device 500 can lock finger pull 502 in place so as to maintainthe treatment device 600 in the deployed configuration. It may also beadvantageous for the delivery tool 500 to have a perceptible (i.e.,audible, tactile, visual) indication that the treatment device has beenfully deployed. The mesh/patch delivery tool 500 may be of the typedescribed hereinabove, or as additionally described in FIGS. 57-62below, or in other sections of this disclosure.

An enhancement to the delivery of the treatment device 600 with meshdelivery tool 500 may include delivery support elements that projectfrom the mesh delivery tool 500 to further enhance the deployment shapeand configuration of the treatment device during deployment and“seating” of the device against annular tissue. FIG. 65 shows a detail,sagittal view of mesh device 600 mounted on the distal portion 602 ofdelivery tool 500, introduced to the cavity having two delivery supportelements 540 passing along the axis of the delivery tool 500 andattached to the treatment device 600. The delivery support elements 540as shown in FIG. 65 may be of a variety of constructions and materials;although, as depicted in one embodiment of the invention in FIG. 65,they represent sutures or tethers used to support the delivery of thetreatment device. Generally, each delivery support element in FIG. 65 isa suture line that follows a “looped” pathway from the proximal end ofthe delivery tool to the distal end of the delivery tool, through thetreatment device, and returns back to the proximal end of the deliverytool, wherein each end of the suture is attached to a proximal actuatingmember of the delivery device, such as finger grip assembly 502.Distally, and in more detail as seen in FIG. 69, the suture line ofdelivery support element 540 passes: through a proximal portion of themesh into a distal portion within the mesh (540—the proximal detachableportion of 540), out of the mesh and back into the mesh in a distalportion of the treatment device, and then back out of a proximal portionof the mesh. Upon deployment of mesh delivery tool 500, delivery supportelements assist in the deployment of the treatment device 600 andfacilitate “seating” of treatment device 600, as may be required, to afinal configuration that abuts, conforms, or otherwise is in proximityto the tissues in need of repair, as shown FIG. 66. FIG. 66 is similarto FIG. 43 except that the delivery tool is enhanced with deliverysupport elements 540. Delivery support elements 540 advantageouslyprovide increased “leverage” by treatment delivery device 500 tocontrollably deliver, deploy and open a treatment device in a locale andconfiguration as desired. Additionally, the delivery support elementsallow a surgeon to “pull back” and seat a treatment device against morerigid tissue, such as the outer layers of the annulus, while notbuckling or otherwise deforming the treatment device during the seatingprocess as it is pulled through softer tissues such as nucleus pulposusand the inner layers of the annulus fibrosus. Importantly, the deliverysupport elements allow a more reliable delivery of a treatment devicewhich is extremely important for a surgeon since there is no easy way tovisualize adequate delivery of the implant.

FIGS. 65 and 66 depict a mesh delivery tool 500 having two deliverysupport members 540 arranged in a caudal/cephalad arrangement, althoughthe number of delivery support elements and their arrangement could bevaried depending on the treatment device support needed and the finaldeployed configuration desired. For example, delivery tool 500 could beconstructed to use only a single delivery support member 540 to directthe deployment of the treatment device in a single direction.Alternatively, multiple support elements can be used to control the meshdeployment in multiple directions, for example, in fourdirections—medial, lateral, cephalad and caudal, or any otherarrangement that advantageously situates the treatment device in adesired configuration. FIGS. 65 and 66 depict an arrangement of thedelivery support elements being located cephalad and caudal to anannular aperture, although this is for illustration purposes only and amedial/lateral arrangement could also be employed.

Controlled delivery, seating and deployment of the treatment device mayalso be beneficial in optimally opening the treatment device toaccommodate the fixation of the device to annular tissue, with variousmeans as described herein.

Although the previous description describes the deployment of thesupport elements as being attached to the same actuator as the treatmentdevice, and delivered at the same time as the deployment of thetreatment device, it is also possible that separate actuators could beemployed to deliver the functioning of the support elements separatelyfrom the treatment. For example, support elements may be attached to aseparate actuator to actuate the support elements before, during, orafter the deployment of the treatment device.

FIG. 36 next depicts a fixation element or anchor band delivery device400 introduced through surgical incision 208, where the distal end 402is passed through the annulus fibrosus 202 adjacent to the aperture 214,and subsequently through treatment device 600, as illustrated by arrow190. Fixation element delivery tool 400 may have features to providetactile feedback once the delivery tool has been introduced into tissueto an acceptable extent, for example a feature like tissue-stop 432. Asillustrated, delivery device 400 is passed distally until stop 432 andpledget member 309 of the fixation device 308 come in contact with theouter surface of the annulus. Alternatively, and without tissue stop 432use, pledget member 309 could be of construction to similarly resist, orotherwise visually or tactilely indicate ceasing the passage of deliverydevice 400 through annular tissue. FIG. 44 shows a detail, sagittal viewof a distal end of a fixation element delivery tool 400 introduced intodisc tissue and through treatment patch 600. As shown in FIG. 44, onefixation element has been deployed and fixated. FIG. 44 also depicts anexemplary treatment device detection feature on the outer surface ofneedle cannula 428, as more clearly illustrated in FIG. 48. The patchdetection feature 442 on the distal end of needle cannula 428 mayadvantageously provide perceptible feedback (tactile and/or audible) tothe surgeon that the anchor band delivery tool has accessed andpenetrated the patch and it is therefore acceptable to deliver the band.Feature 442 is discussed in more detail below. In operation asillustrated in FIG. 36 and in FIG. 37, the delivery device 400 can bemanipulated similarly to the treatment device delivery tool. Forexample, moving finger grip 404 in the direction of arrow 304 willwithdraw a portion (for example, the slotted needle cannula 428) ofdistal end 402 of the device 400 and deploy a fixation element 308, asmore described below, in the subannular cavity 212 to secure thetreatment device 600. The pulling of the finger grip 404 may be precededby the release of a safety lock 406 preventing deployment of thefixation element until intended by the surgeon. As illustrated here, thesafety 406 is released through rotation of safety 406 in the directionof arrow 306. The fixation element delivery tool 400 may be of the typedescribed hereinabove, or as additionally described in FIGS. 47-56below, or in other areas of this disclosure

FIG. 37 depicts the deployment of a fixation element, 308 into disctissue following the deployment of FIG. 36. The fixation device may beas described above, for instance a T-anchor, suture, tether, knot,pledget or barb. As illustrated here, the fixation element 308 is aT-anchor with suture bodies, knot, and pledget as more fully describedbelow. During the pulling of finger grip 404 and retraction of slottedneedle cannula 428, a knot pusher end 406 of inner cannula 426 is shownholding a proximal portion of the fixation device's 308 slip knot 440,while T-anchor 316 is drawn in tension proximally by tether or sutureline 310, to adjust the length of the fixation element 308 to providethe proper tension to securely hold the treatment device 600 in situ. Aproximal end of the fixation element, such as a pledget 309, is held orurged into engagement with a bearing surface on the exterior of theannulus. The proximal end of the fixation device can also include aT-anchor or knot or similar tissue locking element. FIG. 48 is a crosssectional view of the distal end of delivery tool 400 as it may beintroduced in disc tissue. FIG. 55 shows the distal end of the deliverytool 400 after retraction of the slotted needle cannula 428 andtensioning and drawing T-anchor 316 proximally to a potential finalstate. The proximal drawing of T-anchor 316 is also illustrated in adetail, sagittal view in FIG. 45, with arrows 324 illustrating motion ofthe T-anchor. The construction of the locking element 316 is exemplaryand is not intended to be limiting of alternative constructions of 316,such as one or more pledgets, knots, barbs or other forms to effect thesame function.

FIG. 38 shows the partial withdrawal of the fixation element deliverydevice once the fixation element has been deployed. In the illustrationsshown, the final step during the pulling of finger grip 404 proximallyresults in the release of the fixation element in situ. The release maybe accompanied by visual or tactile or auditory confirmation, such as aclick. Once released, the fixation element delivery tool can becompletely withdrawn as shown in FIG. 39, leaving the suture body 310 ofa fixation element extending through the surgical incision 208. Theproximal portion of suture body 310 may be cut to a suitable length withreadily available surgical tools such as a scalpel or surgical scissorsand removed from the surgical site. FIG. 43 shows a detail, sagittalview of a single deployed anchor band assembly 308 with T-anchor 316,pledget 309, slip knot 440 and associated tether components 318 and 310(after it has been cut in the epi-annular space). Also shown areportions or sections of intervertebral disc tissues. As shown, fixationelement 308 is fixedly engaged with the disc tissue and the patch 600.FIG. 40 depicts the treatment device 600 after placement of 2 fixationdevices 308, as does FIG. 46 shown in a detail, sagittal view. Ofcourse, any number of fixation devices appropriate to secure thetreatment device 600 can be used. It is also anticipated that device 600may be of a construction and design, as described herein, that does notnecessitate anchor bands to effect securement of device 600 within thedisc space and, therefore, illustrations using fixation elements are tobe exemplary, not limiting. Once secured, the treatment device 600 isreleased from the delivery tool 500. As illustrated here, this isaccomplished in a two-step process. First the release mechanism isenabled by rotating knob 506 in the direction of arrows 312. Anindicator may then be activated as shown by arrow 320 of indicator 508in FIG. 41, such as spring-loaded release indicator 508 to notify thesurgeon that the treatment device has been released from the deliverytool 500. Accompanying the deployment of indicator 508 is the uncouplingof the treatment device 600 at the distal end 602, as will be describedin greater detail below. The delivery tool 500 can then be withdrawn asdepicted in the transverse view of FIG. 41, leaving treatment device 600in situ.

FIGS. 47-53 depict illustrative embodiments of an fixation elementdelivery tool (or FEDT) as discussed above, which may be referred toalternatively as an anchor band delivery tool (or ABDT). The fixationelement 308 is depicted as loaded in the distal end 402 of the ABDT,which will be discussed in greater detail with reference to FIG. 48. TheABDT 400 is comprised of a main body member 410 which may be fixedlyattached distally to outer cannula 422, and also to inner cannula 426 atinner cannula anchor 438. Distally, inner cannula 426, as betterillustrated in detail in FIG. 48, may comprise a knot pusher (or othermeans to effect securement of suture tethers 310 and 318 with lockingelement 440) and T-anchor stand-off 434. Proximally, main body 410 hasdisposed safety member 406 with an outside diameter telescopically androtatably received in the inner diameter of a knob 408. Knob 408 andmain body member 410 are rigidly attached to one another Slidablydisposed within the lumen of the main body member 410 is sutureretention block 414, depicted with suture body 310 threaded through itscenter hole. A spring 316 is also slidably disposed within the lumen ofthe main body member and can abut either suture retention block 414 orslider member 418. Slider member 418 can be integral with finger grip404 (not shown) as depicted in FIGS. 36-38. Attached to the proximal endof slider member 418 is a suture cutting blade assembly 420. The bladeassembly, as will be discussed in greater detail below, serves to severthe suture body after deployment of the fixation elements as describedherein. A slot in the slider member 418 allows the slider member 418 toslide past the outer cannula anchor 426 and, as described previously,426 may be stationary with respect to main body 410. A slotted needlecannula 428, slidably disposed in the lumen of the outer cannula 422, issecured the distal end of slider member 418 by needle cannula anchor430, such that the translation of the slider member 418 within main bodymember 410 concomitantly translates the slotted hypotube 428 within theouter cannula 422.

FIG. 48 is a detailed view of the distal end 402 of the ABDT 400. Asdescribed above, the slotted hypotube 428 is slidably received in theouter cannula 422. A tether, consisting of a suture line 318 and apledget body 309 is located in proximity to an optional tissue stop 432on the outer cannula 422. It is also possible for pledget 309 to be heldby an optional outer cannula pledget holder 433 until release of theanchor band. The suture line 318 is slidably knotted to suture body 310.The distal end of suture body 310 is attached to T-anchor 316, which isheld by T-anchor stand-off 434. As described above, T-anchor stand-off434 and knot pusher 436 may be components of inner cannula 426. In theinitial configuration, needle hypotube 428 extends distally of outercannula 422 and allows the point of slotted hypotube 428 to extenddistally of the T-anchor holder 434.

FIGS. 47 and 48 depict the ABDT in its initial delivery configuration.The ABDT is locked in this configuration by the distal end of safety 406engaging the finger grip 404 (not shown) as depicted in FIGS. 36-38.Turning now to FIG. 36, the rotation of handle member 406 in thedirection of arrow 306 allows the finger grip 404 (not shown) to engagea slot on safety 406, and permits the surgeon to pull finger grip 404proximally toward the proximal knob 408. Doing so results in thetranslation of the slider member 418 proximally, and concomitantly, theproximal translation of the slotted needle cannula 426 (as a result ofslotted needle cannula anchor 430) in the direction of arrow 326(illustrated in FIG. 45). The result, as discussed above, is theunsheathing by the needle 428 of T-anchor 316 held by T-anchor holder434. The translation of the slide body 418 proximally also urges thespring 416 and suture retention block 414 proximally. The sutureretention block 414 is attached to suture body 310, and thereforetension is leveraged onto the suture body 310 to hold it taught and,when appropriate, draw T-anchor 316 from within the delivery tool to aposition proximally.

FIGS. 50 and 51 illustrate the partial deployment of anchor bandassembly from ABDT, wherein slotted needle cannula 428 has beenpartially retracted to expose T-anchor 316. FIG. 49 is a detailed,cross-sectional view of the distal end of the handle of ABDT 400,illustratively showing the interrelationships of delivery toolcomponents in the initial configuration and FIG. 52 is a similardetailed, cross-sectional view showing the inter-relationships after atleast a partial deployment of device 400. FIG. 53 is a detail of thesuture retention body 414, suture body 310, spring 316 and cuttingassembly blade 420, during partial deployment of delivery tool 400, asdiscussed above.

As depicted in FIG. 54 and detail drawings of FIGS. 55 and 56, as sliderbody 418 continues to slide proximally, in addition to continuing todraw T-anchor as shown in FIG. 55 with arrows, the tether retentionblock 414 reaches the limit of its proximal translation (discussedfurther below), and the slider member engages and compresses spring 316.As the spring is compressed, the blade assembly 420, which is alignedwith the hole of suture retention body 414 through which suture body 310passes, comes into engagement with the suture body 310. FIG. 56 is adetail view of the blade 420 severing the suture body 310. Up to thelimit of travel of the suture block 414 and the severing of tether 310,the suture body 310 continues to apply tension to the T-anchor, as shownin greater detail in FIG. 55. With knot pusher holding knot 440, pledget309, and suture 318 in apposition, and in distally exerted fashion, tothe tensioning of suture body 310, anchor band assembly 308 isadvantageously cinched into a fixing and/or compressive relationshipbetween ends 309 and 316, as well as any structures (e.g., nucleus,annulus, treatment device) between elements 309 and 316. After severingsuture body 310, suture body 310 is still attached, to the anchor band,but has at this point been severed proximally. The suture body 310 willtherefore be unthreaded from the interior of the ABDT as the ABDT iswithdrawn. As discussed above the suture line 310 may be further cut tolength with readily available surgical scissors. Alternatively, asevering mechanism similar to those described herein in the distalportion of tool 400 may be employed to avoid an additional step oftrimming the end of body 310.

FIG. 53 is a detail of the suture retention body 414, suture body 310,spring 316 and cutting assembly blade 420, during partial deployment ofdelivery tool 400, as discussed above

Additionally inventive of the anchor band device (and its delivery anddeployment tools) is the unique inter-relationship of the slide body,spring, and the tension delivered to the T-anchor and tissue duringdeployment. For example, T-anchor assembly can be designed to passthrough softer or otherwise more pliable tissues (e.g., nucleuspulposus, softer annular layers) while resisting, under the sametension, passage through tougher tissues and/or substrates (e.g., outerannular layers, treatment device construct). In further illustrativedescription, tension delivered to the suture line 310 can be limited bythe interface between the slide body member 318 and the suture retentionblock 414, through spring 316 such that tension is exerted on T-anchorbody 316 which may sufficiently allow movement of T-anchor 316 throughsofter tissue, but alternatively requires a greater force to pullT-anchor body through other materials or substrates such as thetreatment device 600 or outer layers of the annulus 202. Spring 316 canbe designed to sufficiently draw tissues and/or the patch together,while not overloading suture line 310 when the fixation has beeneffected. Spring 316 may also be advantageously designed to allow bladeassembly 420, upon reaching an appropriate loading to effect thedelivery, to sever the suture line 310. An illustrative example, but notintended to be limiting, T-anchor body and suture line may beconstructed to require approximately 5 pounds of force to draw theT-anchor assembly through nuclear tissue, but substantially greater loadto draw T-anchor through annular tissue and/or patch device. Spring maybe designed to exert approximately 5 pounds, sufficiently pulling anchorthrough nuclear tissue, and in proximity to treatment device, asintended. Once sufficient load has been applied to move T-anchor toengage patch, the loading on the suture line is not allowed tosubstantially increase. Advantageously, additional loading would causethe final compression of spring between suture retention block and bladeassembly to sever suture line. Preferably, the severing and the designof the tether elements are such that the ultimate strength of the sutureline is greater than the load required to draw T-anchor through softtissue, or the like, and less than the load inflicted to cause thesevering by blade assembly. The description herein is intended to beillustrative and not limiting, in that other device and delivery toolscould be derived to employ the inventive embodiments.

FIGS. 57-62 depict illustrative embodiments of a therapeutic devicedelivery tool (TDDT), or mesh delivery tool (or MDT) as discussed above.The treatment device (or mesh or patch) 600 is depicted as loaded in thedistal end of the TDDT 500, which will be discussed in greater detailwith reference to FIG. 58. The TDDT 500 is comprised of a main bodyhousing 510 which may be fixedly attached distally to outer cannula 522,which in a lumen thereof slidably receives a holding tube assembly 526.Distally, holding tube 526, as better illustrated in detail in FIG. 58,may comprise a slotted end and accommodate an actuator rod or stylet 514in an inner lumen. Proximally, main body 510 has disposed thereon safetymember 504, and has an outside diameter telescopically and rotatablyreceived in the inner diameter of cap 506. Cap 506 forms part of end capassembly 524, which also comprises ball plunger assembly 536, which willbe described in greater detail below. Slidably disposed within the lumenof the main body member 510 is actuator body assembly 518, which abutsat its distal end, optionally in mating fashion or via detents, againsta proximal end of finger grip member 502, which is also slidablydisposed in the lumen of main body 510. At the proximal end of theactuator body assembly 518 is formed device release indicator 508, whichwill be described in greater detail below. A spring 516 is also slidablydisposed within the lumen of the main body member and can abut eitheractuator body assembly 518 or finger grip member 502. The finger gripmember can optionally comprise finger members at a distal end, carryingdetents to engage with tabs, slots, or other cooperative structure onthe inner lumen of main body 510 to lock the finger grip member,aggressively or gently, in the undeployed (unused) or deployed (used)configuration. A holding tube assembly, in the form of a slottedhypotube needle cannula 526, is slidably disposed in the lumen of theouter cannula 522, and is secured to the distal end of actuator bodyassembly 518, such that the translation of the finger grip member 502proximally within main body member 510 concomitantly translates theactuator body assembly 518, and thus holding tube assembly 526 withinthe outer cannula 522.

FIG. 58 is a detailed view of the distal end 602 of the TDDT 500. Asdescribed above, the holding tube assembly 526 is slidably received inthe outer cannula 522. The TDDT is designed to releasably deploy thetreatment device 600 after the distal end 602 is navigated by thesurgeon to the intended deployment site. The treatment device 600, shownin cross section and discussed further below, comprises a proximal end,forming a collar or cuff 604, and a distal end, also forming a collar orcuff 606. The proximal end 604 is slidably disposed on holding tubeassembly 526, and abuts and is held stationary by outer cannula 522. Thedistal end of the holding tube assembly 526 can be formed to carrytreatment device latch 608. The device latch 608 is formed with a flangeor other detent to engage the distal end of treatment device 600,preferable the distal most end of distal collar 606. The slotted end ofholding tube assembly 526 is held radially rigid by actuation rod 514,such that the treatment device 600 is held firmly on the distal end 602of the TDDT 500.

FIGS. 57 and 58 depict the TDDT in its initial delivery configuration.FIG. 67 depicts the treatment device delivery tool 500 of FIG. 57 withan additional inventive embodiment of delivery support elements 540. Oneend of each delivery support element 540 (illustratively FIG. 67 revealstwo delivery support elements) may be fixedly attached to the proximalportion of the delivery tool 500 and may be actuated by, for example,finger grip 502. The other end of the delivery support element 540 maybe releasable attached to the proximal end of the delivery tool 500. Forexample, 540 is temporarily affixed in between the junction of actuatorbody 518 and finger grip 502 in FIG. 67. Initially, with or without theadditional use of delivery support members, the TDDT of FIGS. 57 and 58is locked in this configuration by the distal end of safety 506 engagingthe finger grip 502. Turning now to FIG. 59, the rotation of safety 506in the direction of arrow 302 allows the finger grip 502 to engage aslot on safety 506, and permits the surgeon to pull finger grip 502proximally in the direction of arrow 300 toward the proximal cap 506.Doing so results in the translation of the slider member 518 proximally,and concomitantly, the proximal translation of the holding tube assembly526. The result, as further illustrated in FIG. 60, is the movement ofthe distal end 606 of treatment device 600 moving toward the proximalend 604, resulting in a bulging or lateral expansion of the treatmentdevice 600. The translation of the actuator body assembly 518 proximallyalso urges the device release indicator 508 proximally, as will bediscussed further below. As can be seen in FIG. 68, the delivery oftreatment device may be enhanced with delivery support elements 540,which also move with slider member 518 and finger grip 502 and result inthe delivery of the treatment device as seen in FIG. 69.

FIG. 60 depicts the distal end of the TDDT 500 after fully withdrawingthe finger grip member 502 proximally, as discussed above (or FIG. 69for enhanced delivery with delivery support members). When the fingergrip has reached the limit of its intended travel upon being pulled by asurgeon, the treatment device 600 will be in its deployed configuration.In this configuration, detents on the proximal end of treatment devicelatch 608 will be poised to engage the proximal end 604 of treatmentdevice 600 to hold it in the deployed state. As illustrated in FIG. 60,the actuation rod 514 can be seen to hold the distal end of the holdingtube assembly 526 engaged with the distal end 606 of the treatmentdevice 600, providing for maneuverability or removal until released.

FIGS. 61 and 62 illustrate the final deployment of the treatment device600 just prior to withdrawal of the TDDT. As shown in FIG. 61, therotation of cap 506 in the direction of arrow 312 releases actuator bodyassembly 518 from ball plunger 536, permitting its translationproximally under the bias of spring 516. Translation of the actuatorbody assembly 518 withdraws actuator rod 514 in the proximal direction,which permits the release of the treatment device 600 from the distalend of the TDDT, as further described with reference to FIG. 62. Thetranslation proximally of actuator body assembly 518 permits indicator508 to emerge from a hole in the cap 506, providing a perceptibleindication to the surgeon that the TDDT can be removed and will leavethe treatment device in situ. Turning to FIG. 62, the withdrawal of theactuation rod 514 is illustrated, which allows for inward radialcompression of the tip of the holding tube assembly 526. Once the distalend of the holding tube assembly 526 is compressed radially inwardly, itcan then pass through the inner diameter of the treatment device latch608, and allow withdrawal of the entire TDDT from the treatment device600. The final disengagement of the distal end of the outer cannula 522can advantageously permit the engagement of detents on the treatmentdevice latch 608 to engage the proximal collar 604 of the treatmentdevice 600, locking it in a deployed configuration.

In an alternative embodiment utilizing an enhanced delivery of atreatment device, FIGS. 70 and 71 depict the final configurations of adelivery tool 500 with delivery support elements 540. FIG. 70illustrates the release of the releasable end of support element 540from the juncture between the actuator body 518 and the finger grip 502after rotation of knob 506. Free ends of support elements 540 may nowtravel distally down along the shaft of the delivery tool, through themesh implant, and be releasably detached from the delivered mesh. FIG.71 shows the motion 542 of the end of support element 540 passingdistally through the mesh as the delivery tool is being withdrawn fromthe treatment device. In this embodiment, delivery support elements areremoved from the treatment device after its acute placement.

Additionally inventive of the treatment device (and its delivery anddeployment tools) is the unique inter-relationship of the actuator body,spring, and the holder tube assembly, allowing the device to be deployedwhile still holding the device firmly during deployment. The use of theactuator rod to stiffen the distal end of the small diameter outercannula, and the use of a radially compact treatment device offersadditional advantages, such as the ability to pass through softer, orotherwise more pliable tissues (e.g., nucleus pulposus, softer annularlayers) while resisting columnar bending during navigation. As anillustrative embodiment, a mesh patch as described in FIGS. 63 and 64can be employed, but such a device configuration is not intended to belimiting. Other devices that expand radially through linear actuationcan also be used.

The spring may be designed to exert approximately 5 pounds, sufficientto provide tactile control while preventing inadvertent release of thetreatment device. By requiring actuation of the device in a differentdirection for release (i.e., rotation of the proximal cap) than thatrequired for initial deployment (i.e., proximal translation of thefinger grip), each with tactile, auditory or visually perceptibleconfirmation, safe and affirmative deployment can be achieved.

FIGS. 63 and 64 depict anterior views of the distal end 602 of the TDDTand treatment device 600 following deployment. FIG. 63 shows the distalend of holding tube assembly 526 engaging the treatment device latch608. FIG. 64 shows the distal end of 526 disengaged, followingwithdrawal of the actuation rod 514 as discussed hereinabove.

FIG. 72 illustrates a further embodiment of an enhanced delivery of atreatment device 600 through the use of delivery support elements 540and a support element collar 544. Support element collar 544 may act tohold the support elements distally and to guide elements' travel alongthe shaft of the treatment device delivery tool 500. The collar may beconstructed to allow the support elements to movable pass through thecollar, and thus the collar may remain relatively stationary along theTDDT shaft, or conversely, the collar may be affixed to the elements andbe movable along the TDDT shaft. It is also contemplated that the collarcould have a limited dimension along the shaft, serving principally as aguide for support elements 540; or conversely, collar 544 could extendalong a significant portion of the shaft of delivery tool 500,resembling a tube along the outer shaft of delivery tool 500. The latterconstruction may provide increased leverage and support to the deliverysupport elements. It is contemplated that a variety of biocompatiblematerials may be used to construct the collar, such as, but not limitedto: polymers, metals, ceramics, synthetics, engineered, shape memory,biodegradable/bioresorbable.

Exemplary delivery support elements 540 have been characterizedpreviously, for exemplary reasons only, as sutures; although it iscontemplated that the construction of the support elements may takevarious forms such as rods, beams, bars, wires, bands, tubes or otheractuating elements to assist in the deployment, opening, seating orotherwise delivery of a treatment device. For example, FIG. 73 depicts adevice support element constructed of a tube and an attachment element548 to releasably attach the support element 540 to the treatmentdevice. The attachment element 548 is released after the delivery of thetreatment device and the support element is removed with the TDDT 500.It is also anticipated that attachment element may take a variety offorms to allow attachment of support element 540 to treatment device600, including but not limited to: hooks, latches, knots, clips, grips,fasteners, pins, staples, clasps, slides or other attachment means.Support elements and collars may be comprised of a variety ofbiocompatible materials, including, but not limited to: polymers, metalsand metallic alloys, ceramics, synthetics, engineered, shape memory,biodegradable/bioresorbable.

In addition to delivery support elements that are releasably attached tothe treatment device 600, and therefore may be removed with the deliverydevice 500, it is contemplated that some embodiments of the inventionmay include delivery support elements that may partially, or wholly,remain an integral part of the implanted treatment device. For example,FIG. 74 depicts an exemplary embodiment wherein a support element may beconstructed of, for example, a suture with knots along its length. Oneend of the suture is affixed to a distal end of the treatment device.Proximally, the proximal end of treatment device may have deliverysupport element latch 546 configured to lockingly receive portions of asupport element 540. When support element 540 of FIG. 74 is drawnproximally in a direction depicted by arrow 542, while the treatmentdevice is deployed, elements along 540 may engage with the proximalportion of the treatment device to secure support elements when thetreatment device is in an expanded configuration. As illustrated, asuture line with knots is depicted to illustrate the use of anembodiment of support elements that may remain with the treatment deviceafter deployment, however there may be a variety of differentconstructions of a support element 540 as well as means to lockinglyattach the support element to the treatment device, utilizing forexample, hooks, latches, anchors, clips, grips, fasteners, pins,staples, clasps, slides, or other attachment means. These supportelements may be formed from a variety of biocompatible materialsincluding, but not limited to: polymers, metals,biodegradable/bioresorbable, natural, synthetic, genetically engineered.

An additional exemplary embodiment of a support element that may be anintegral portion of treatment device can be seen in FIG. 75. Deliverysupport elements 540 assist in the opening, deployment, seating andotherwise delivery of treatment device 600. Support elements 540 may beconstructed of an elastic material, allowing the device to obtain theconfiguration in FIG. 75 when the device is deployed. Elements 540 actas “tension bands” to support the opening of the device and providetension when “seating” the device against tissue. Elements may beconstructed of a variety of biocompatible materials, such as: polymers,metals, synthetic, natural, engineered, superelastic alloys, shapememory, biodegradable/bioresorbable, etc.

Since the surgeon's visualization during discectomy procedures istypically limited to the epi-annular space and the aperture at theoutside surface of the annulus, any tactile, visual or audible signalsto assist, or otherwise enhance, the surgeon's ability to reliablydeliver and deploy treatment devices may be advantageous. Assisting thedelivery with the inventive enhanced delivery embodiments with deliverysupport elements described herein may allow for increased reliability ofdelivery and fixation of a treatment device for the repair of annulartissue. Exemplary materials that could be used to construct the variousdelivery support elements and collar attachment elements include, butare not limited to: biocompatible polymeric materials (polyester,polypropylene, polyethylene, polyimides and derivatives thereof (e.g.,polyetherimide), polyamide and derivatives thereof (e.g.,polyphthalamide), polyketones and derivatives thereof (e.g., PEEK, PAEK,PEKK), PET, polycarbonate, acrylic, polyurethane, polycarbonateurethane, acetates and derivatives thereof (e.g., acetal copolymer),polysulfones and derivatives thereof (e.g., polyphenylsulfone), orbiocompatible metallic materials (stainless steel, nickel titanium,titanium, cobalt chromium, platinum and its alloys, gold and it alloys),or biodegradeable/bioresorbable materials, or naturally or syntheticallyderived materials.

All patents referred to or cited herein are incorporated by reference intheir entirety to the extent they are not inconsistent with the explicitteachings of this specification, including; U.S. Pat. No. 5,108,438(Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Rayet al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331(Ducheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No.5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.), U.S.Pat. No. 5,376,120 (Sarver et al.) and U.S. Pat. No. 5,976,186 (Bao etal.).

Various materials know to those skilled in the art can be employed inpracticing the present invention. By means of example only, the bodyportions of the stent could be made of NiTi alloy, plastics includingpolypropylene and polyethylene, polymethylmethacrylate, stainless steeland other biocompatible metals, chromium cobalt alloy, or collagen.Webbing materials can include silicone, collagen, ePTFE, DACRON,polyester, polypropylene, polyethylene, and other biocompatiblematerials and can be woven or non-woven. Membranes might be fashioned ofsilicone, polypropylene, polyester, SURLYN, PEBAX, polyethylene,polyurethane or other biocompatible materials. Inflation fluids formembranes can include gases, liquids, foams, emulsions, and can be orcontain bioactive materials and can also be for mechanical, biochemicaland medicinal purposes. The stent body, webbing and/or membrane can bedrug eluting or bioabsorbable, as known in the medical implant arts.

Further, any of the devices or delivery tools described herein, orportions thereof, could be rendered visible or more visible viafluoroscopy, if desired, through the incorporation of radiopaquematerials or markers. Preferably implantable devices are constructedwith MRI compatible materials. In particular, devices and/or theircomponents could be wholly or partially radiopaque, as result of, forexample: compounding various radiopaque materials (e.g., bariumsulphate) into device materials; affixing radiopaque materials to devicestructures (e.g., bands of platinum, gold, or their derivative alloys);deposition of radiopaque materials onto device structures (e.g.,deposition of platinum, gold of their derivative alloys); processingradiopaque materials into device structures (e.g., braiding/weavingplatinum or gold wires or its alloy derivatives). One inventive way toachieve radiopacity of a device described herein, for example treatmentdevice 600, is placing one or more radiopaque marker bands ontofilaments of braided device 600 before (or possibly after) creating endpotions of the device.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

1. A system for use in the treatment of intervertebral disc tissuecomprising: a therapeutic device including a first end and a second endand an intermediate portion therebetween, the therapeutic deviceconfigured to transition from a first, pre-deployment configuration inwhich the intermediate portion has a radially compact configuration to asecond, post-depoyment configuration in which the intermediate portionhas a radially expanded configuration; a delivery tool including alongitudinal shaft having a proximal end and a distal end carrying thetherapeutic device releasably attached thereto, and at least oneproximal actuating member; and a delivery support element connected tothe therapeutic device and to the delivery tool, the delivery supportelement movable in the longitudinal direction under tension tofacilitate deployment of the therapeutic device from the first,pre-deployment configuration to the second, post-deploymentconfiguration.
 2. The system of claim 1, wherein the delivery supportelement includes a suture line having a first end and a second end. 3.The system of claim 2, wherein the first end and the second end of thesuture line are attached to the proximal actuating member of thedelivery tool.
 4. The system of claim 2, wherein the first end isattached to the proximal actuating member of the delivery tool, and thesecond end is attached to the proximal end of the delivery tool.
 5. Thesystem of claim 2, wherein at least one proximal actuating memberincludes a first proximal actuating member and a second proximalactuating member, and wherein the first end of the suture line isattached to the first proximal actuating member and the second end ofthe suture line is attached to the second proximal actuating member. 6.The system of claim 2, further comprising a finger grip assembly,wherein the proximal actuating member abuts the finger grip assembly,and wherein the second end of the suture line is releasably affixed to ajuncture between the proximal actuating member and the finger gripassembly.
 7. The system of claim 2, wherein the suture line extends fromthe delivery tool and through the therapeutic device releasably attachedto the distal end of the shaft of the delivery tool.
 8. The system ofclaim 2, wherein the second end of the suture line is releasable fromthe delivery tool.
 9. The system of claim 1, wherein the deliverysupport element is releasable from the delivery tool.
 10. The system ofclaim 1, wherein said at least one delivery support element isconstructed from biocompatible polymeric materials, polyamide, polyamidederivatives, polyketones, polyketone derivatives, PET, polycarbonate,acrylic, polyurethane, polycarbonate urethane, acetates, acetatederivatives, polysulfones, polysulfone derivatives, biocompatiblemetallic materials, biodegradable/bioresorbable materials, naturallyderived materials, or synthetically derived materials.
 11. The system ofclaim 1, further comprising a delivery support element collar configuredto distally hold the delivery support element.
 12. The system of claim11 wherein the delivery support element collar is configured to allowthe delivery support element to movably pass through the collar.
 13. Thesystem of claim 11, wherein the delivery support element collar isaffixed to the delivery tool.
 14. The system of claim 11, wherein thedelivery support element collar is movable in the longitudinaldirection.
 15. The system of claim 11, wherein the delivery supportelement collar comprises a tube affixed to the shaft of the deliverytool.
 16. The system of claim 1, wherein the delivery support elementcomprises a tether, a rod, beam, wire, band, tube, or actuating element.17. The system of claim 1, wherein the delivery support elementcomprises a suture line having at least one knot along its length. 18.The system of claim 1, wherein the delivery support element isintegrated with the therapeutic device.
 19. The system of claim 1,wherein at least a portion of the delivery support element is exteriorto said delivery tool.
 20. The system of claim 1, wherein the distal endof the delivery tool shaft comprises a latching element.
 21. A systemfor use in the treatment of intervertebral disc tissue comprising: atherapeutic device including a first end and a second end and anintermediate portion therebetween, the therapeutic device configured totransition from a first, pre-deployment configuration in which theintermediate portion has a radially compact configuration to a second,post-depoyment configuration in which the intermediate portion has aradially expanded configuration; a therapeutic device delivery toolincluding a longitudinal shaft having a proximal end and a distal end,an actuator rod configured to traverse at least a portion of thetherapeutic device, a holding tube assembly having a distal end and aproximal end and slidably disposed within the shaft and sized to receivethe actuator rod, the distal end of the holding tube assembly includinga therapeutic device latch configured to releasably engage thetherapeutic device, a finger grip member at least partially positionedwithin the shaft and abutting the distal end of the holding tubeassembly, wherein the finger grip member is moveable in the longitudinaldirection so that longitudinal movement by the finger grip memberconcomitantly moves the holding tube assembly in the longitudinaldirection, and wherein the finger grip member comprises an orifice sizedto receive the actuator rod; and a delivery support element connected tothe therapeutic device and to the delivery tool, the delivery supportelement movable in the longitudinal direction under tension tofacilitate deployment of the therapeutic device from the first,pre-deployment configuration to the second, post-deploymentconfiguration.
 22. The system of claim 21, further comprising a deliverysupport element collar configured to hold the delivery support elementand located along said shaft.
 23. The system of claim 21, wherein thedelivery support element is engaged with an actuating body assembly sothat longitudinal movement of the finger grip member concomitantlytranslates the actuating body assembly, the holding tube assembly, andthe delivery support element.
 24. The system of claim 21, wherein thedelivery support element is a suture line having a first end and asecond end.
 25. The system of claim 24, wherein the delivery supportelement is engaged with an actuating body assembly, and wherein thefirst end and the second end of the suture line are attached to theactuating body assembly.
 26. The system of claim 24, wherein thedelivery support element is engaged with an actuating body assembly, andwherein the first end of the suture line is attached to the actuatingbody assembly and the second end of the suture line is attached to theshaft.
 27. The system of claim 24, wherein the at least one deliverysupport element is a tether, rod, beam, wire, band, tube, or actuatingelement.